Alli and Xenical: Is there a connection with a rare liver injury?

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Alli and Xenical have been claimed to be linked to a rare form of liver injury says
the FDA.

Worldwide, there have been only 13 cases among the 40 million people who have used the products. Two eople died and three others required liver transplants.

Alli and Xenical contain the weight loss drug orlistat. Xenical, made by Roche's Genentech, contains 120 milligrams of orlistat and is available only by prescription. Alli, from GlaxoSmithKline, contains 60 milligrams of orlistat and is available over the counter.

In 2009, the FDA announced it was reviewing 32 reports of liver injury in people taking Alli or Xenical. That review has now identified 13 cases, one in the U.S., of liver death or liver failure.

According to the FDA

The following factors make confirming a cause-and-effect relationship between orlistat and severe liver injury difficult:

* One U.S. case with Alli and 12 foreign cases with Xenical reported between April 1999 and August 2009 out of an estimated 40 million people worldwide who have used Xenical or Alli.
* Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury.
* Severe liver injury can occur in people not taking drugs and without a distinct cause.

At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established. Because of the seriousness of severe liver injury, FDA has added information about reported cases of severe liver injury to the label of Xenical and Alli to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. The agency is also working with the manufacturer of Alli to ensure that consumers can understand this new warning.

Source.




The labels for Alli and Xenical will now carry warnings about the possible risk of liver injury.

Symptoms of liver injury include:

* Loss of appetite
* Itching
* Yellow eyes or skin
* Dark urine
* Light-colored stools

People concerned about the possibility of liver injury should consult a doctor.

Diet Drug Reviewed by FDA: Orlistat (Xenical)

The FDA said it has received 32 reports of serious liver injury -- including six cases of liver failure -- among users of diet drug orlistat, which is sold as a prescription drug under the trade name Xenical and as an over-the-counter diet aid under the name Alli.

As a result of those reports, the FDA said it had initiated a safety review of the product, which works by blocking the absorption of ingested dietary fats.

Orlistat 120 mg (Xenical) was approved in 1999 for weight loss in conjunction with a reduced caloric diet and for prevention of rebound weight gain after weight loss. The OTC version, orlistat 60 mg, was approved in 2007 for use by overweight adults ages 18 and older.

The FDA said that in addition to the 32 reported cases, orlistat safety "was discussed at the CDER Drug Safety Oversight Board in April 2009, and the FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time."

Source here.